A comprehensive two day course for both new and experienced biotechnology professionals:

• Leveraging Your R&D Dollars
• Grants; Cooperative Research and Development Agreements
• Working With the Food and Drug Administration
• Federal Regulation of Biotechnology
• Selling to the Federal Government
• Forms of Contracting and Commercial Items
• Compliance with Government Contracting Rules and Regulations
• How Government Contracts are Audited
• Protecting Your Intellectual Property
  and more...

The Federal marketplace offers tremendous opportunities for the informed and various traps for the unwary. The Federal government can help fund the research and development of your products during their embryonic stages and provide a substantial marketplace for your products and services after they are developed. But failure to follow the rules can result in the loss of important selling opportunities and valuable intellectual property rights. In fact, inattention to and disregard of the rules can result in civil and criminal liabilities.

Biotech organizations face important selling and compliance issues when providing products and services to the Government. The purpose of this course is to outline and explain the dynamic regulatory requirements of biotech contracting that are developing at the national and international levels. The course provides both an overview of the following lifecycle issues as well as specific guidance on acquisition methods for forward-thinking organizations:

• research and development: leveraging Federal funding for biotech products and partnering with the Federal government.
• product commercialization: the Federal framework for the regulation of products of biotechnology; what biotech products need test and commercial market approval; which agency deals with which products; and--in the case of drugs, what will be approved for payment under Medicare and health insurance policies.
• selling commercial biotechnology products and services to the government; detailed information on how agency ID/IQ contracts operate and the type of investments a company must make in necessary infrastructure resources to support its government contracts; and intellectual property protection issues.
• enforcement of and compliance with government contracting rules and regulations including rules related to procurement integrity; and
• intellectual property and trade issues.

The details are spelled out in the comprehensive Course Curriculum. The course will be presented by a faculty of experienced practitioners whose credentials are outlined below.

We invite your participation.

1. Leveraging Your R&D Dollar--Getting the Government to Help Fund, Conduct, or Underwrite Basic and Applied Research
   1. Mechanisms--Overview
      1. Grants
      2. Cooperative Research and Development Agreements (CRADAs) Under the Federal Technology Transfer Act of 1986, as Amended
      3. Licensing Government Interventions Under Bayh-Dole
      4. Conducting NIH Clinical Trials
   2. Grants to Profit Making Entities
      1. The Grants Process at NIH
      2. Advantages of NIH Grants
         1. Credibility
         2. Retention of IP Rights Under Bayh-Dole
      3. Disadvantages associated with NIH Grants
         1. Numerous Assurances Required--e.g., Conflict of Interest (42 CFR Part 50, subpart F), Scientific Misconduct (42 CFR Part 50, subpart A), Human Subjects (45 CFR Part 46), Animal Welfare
         2. Data Rights and Confidentiality Risk Under FOIA as amended by the Shelby Clause
   3. CRADAs
      1. Legal Basis--Federal Technology Transfer Act of 1986, as amended
      2. Process for entering into a CRADA
      3. Contents of a CRADA
         1. Scope of work
         2. Government Contributions
         3. Private Entity Contributions
         4. Allocation of IP Rights at Outset--Is it possible?
      4. Advantages of CRADAs
      5. Disadvantages of CRADAs
         1. Licensing Back from Government is Time Consuming
         2. Royalties Tend to be Higher, Especially for Small Company, Than One Would See in the Private Sector
      6. Practical Suggestions for Getting the Most Out of a CRADA Relationship
   4. Licensing Government Inventions
      1. Legal Basis--Bayh-Dole, 35 U.S.C. 201 et seq.
      2. Licensing Process
         1. Exclusive License
         2. Non-Exclusive License
   5. NIH-sponsored Clinical Trials
   
   
2. Moving From the Bench to the Bureaucracy--Federal Regulation of Biotechnology
   1. The Food & Drug Administration Federal Food, Drug, and Cosmetic Act
      1. Differentiating Drugs, Biologics and Devices
      2. Pre-clinical Trial Requirements
         1. In vitro and in vivo testing
         2. GLPs and GMPs
      3. Approval Processes--Steps, Costs and Time
         1. Obtaining an IND/IDE
         2. Implementing an IND/IDE--Various Phases
         3. NDA/BLA/PMA
      4. Post-Marketing Requirements
   2. USDA
      1. Plants, Trees and Animals
      2. Research and Environmental Release Requirements
      3. Approval Processes for Commercial Applications
      4. Post-Marketing Requirements
   3. EPA--Federal Insecticide, Fungicide and Rodenticide Act; Toxic Substances Control Act
      1. Plant and Biopesticides
         1. Definitions
         2. Data Requirements
         3. Approval Processes
         4. Post-Marketing Requirements
      2. Toxic Substances; Pre-Market Notification Requirements
         1. Definitions
         2. Data Requirements
         3. Approval Processes
         4. Post-Marketing Requirements
   
   
3. Interacting With the Food and Drug Administration: Pitfalls for the Unwary
   1. The FDA Approval Process
   2. Conducting Clinical Trials
      1. Assessing Whether Your Organization is Financially and Technically Able to Conduct Trials
         1. GLP and GMP
         2. Conflict Issues
         3. Fast Tracking
         4. Multi-Center Trials
         5. Responsibilities of a Sponsor
      2. Designing Trials to Promote Favorable Coverage Decisions Where Relevant
      3. Ethical Considerations and Restrictions on Human Subjects Research
         1. Common Rule and How It is Applied by FDA
         2. Special Restrictions Concerning Gene Therapy and Recombinant Technology
      4. Restrictions on What Can be Said While Conducting a Clinical Trial
   3. Protecting Your Product--Patent Listing in the Orange Book
   4. Patent Term Extension Under Hatch-Waxman
   
   
4. Selling Biotechnology Products and Services to the Government Customer
   1. Unique Customer
      1. World's Largest Consumer of Commercial Item Goods and Services
      2. Regulation of Purchasing Process
      3. Notable Clauses
         1. Termination
         2. Changes
         3. Intellectual Property
      4. Role as Regulator
         1. Procurement/Contracts--Audits, Investigations
         2. Scientific Approval--NIH, FDA, CDC, HHS
   2. Typical Selling Vehicles Available to Industry
      1. Credit Card Purchases
      2. Indefinite Delivery/Indefinite Quantity (ID/IQ) Contracts
         1. Blanket Purchase Agreements (BPAs)
         2. Basic Ordering Agreement (BOAs)
      3. Negotiated Procurements
      4. Reverse Auctions
   3. GSA/VA Schedules
      1. Popularity and ease of use
      2. Most Favored Customer Treatment
      3. Subject of Negotiations With Contracting Officer
         1. Discount/Net Price for Biotechnology Products/Services
         2. Benchmark Customer
         3. Maximum Ordering Threshold
      4. Contract Award Process/Performance Issues
      5. Industrial Funding Fee
      6. Price Reduction Clause
      7. Pros and Cons of Schedules
   4. Biotechnology Business Considerations
      1. Commitment of Organization to Government Marketplace
      2. Necessary Infrastructure and Resource Investments
   
   
5. Trade Issues--Foreign Participation in U.S. Government Procurement
   1. Foreign Source Restrictions
      1. Buy America Act/Trade Secrets Act/Balance of Payments Program
      2. Other Foreign Source Restrictions
   2. Prohibition on the Export of Data Ancillary to U.S. Government Contracts
      1. International Traffic in Arms Regulation (ITAR)
      2. Export Administration Regulation (EAR)
   
   
6. Intellectual Property Issues
   1. Patent
   2. Rights in Technical Data
   
   
7. Government Contract Compliance--An Ounce of Prevention is Better Than a Pound of Cure
   1. Overview
   2. Compliance--Why You Should Care
   3. False Claims Act
      1. Elements of the Change
      2. Damages
      3. Ancillary Damages
      4. Suspension and Debarment
   4. Compliance
      1. Reasons for an Effective Compliance Program
      2. Elements of an Effective Compliance Program
      3. Present Responsibility--What It is and Why It is Important
      4. Past Performance Considerations
   5. Procurement Integrity Issues
      1. Gratuities
      2. Hiring Government Employees--Revolving Door Issues
      3. Exchange of Confidential Information
      4. Contingency Fees
      5. Gratuities from Subcontractors, Anti-Kickback Act
      6. Organizational Conflicts of Interest

THE COURSE FACULTY

Faculty members are practitioners in the Washington, D.C. law offices of the prestigious law firm of Crowell & Moring, LLP.

James J. Regan is a partner in the Washington, D.C. law firm of Crowell & Moring. He represents clients in a wide variety of Government Contract matters, including compliance reviews and multiple award schedule issues. His experience includes health care and life sciences issues, compliance reviews, and other contract counseling.

Formerly Chief Counsel with the General Services Administration Board of Contract Appeals, he is a frequent lecturer and author on Federal Procurement topics, including responsibility for the Federal Publications GSA Schedule and Computer Software Courses.

Mr. Regan is a magna cum laude graduate of Georgetown University and received his law degree from the Georgetown University Law Center.

Nancy Bryson is a partner in the law firm of Crowell & Moring where she specializes in the management and resolution of legal issues arising out of the health, safety and environmental regulation of consumer and commercial products. Ms. Bryson is the liaison of the D.C. Bar to the Law and Science Academy and a vice-chair of the ABA Committee on Chemical Regulation, Pesticides and Right-to-Know. Prior to joining Crowell & Moring, Ms. Bryson served as a trial attorney and Assistant Chief of the Environmental Defense Section at the U.S. Department of Justice and in the Office of Solicitor for Occupational Safety and Health at the U.S. Department of Labor.

John E. McCarthy, Jr. is a special counsel in the Washington, D.C. office of Crowell & Moring. He received his degree in engineering science from Rockhurst College, his Master's degree in electrical engineering from Catholic University and his J.D. from Catholic University. Mr. McCarthy practices in the areas of government contracts and litigation of technology-related issues.

Prior to joining Crowell & Moring, Mr. McCarthy worked for ten years designing and developing a variety of computer and communication systems for various companies, including IBM Corporation and the Jet Propulsion Laboratory.

Mr. McCarthy is an active member of the ABA Public Contracts Law Section having served as vice-chair of the Information Systems Committee. He is the co-author of a chapter in the Manual of Foreign Investment in the United States concerning foreign participation in U.S. Government procurement.

Marc Efron is a partner in the Washington, D.C. office of Crowell & Moring, where he specializes in government procurement law. He graduated with high honors from Dartmouth College and is a graduate of Harvard Law School.

Marc's practice principally involves counseling and representing clients in the award and performance of government contracts. He represents clients in civil matters and he litigates before various Boards of Contract Appeals, the General Accounting Office, the Court of Federal Claims, and numerous federal and state courts.

Marc is a member of the District of Columbia Bar and the American Bar Association. He lectures frequently on government procurement issues including Federal Supply Schedule contracts, protests of contract awards, environmental issues confronting government contractors, government investigations of procurement fraud, and terminations for the convenience of the government.

Robert P. Charrow is an attorney with the Washington, D.C. law firm of Crowell & Moring where he specializes in health care law and legal issues associated with federally funded or regulated research in the biomedical sciences. He represents health care providers, universities, research institutions, pharmaceutical companies, and other entities in a broad range of issues including matters arising under the Medicare and Medicaid programs, the Public Health Service Act, the Bayh-Dole Patent Amendments, the Federal Technology Transfer Act of 1986, the False Claims Act, and the Administrative Procedure Act.

Prior to joining Crowell & Moring, he served as the Principal Deputy Counsel for the U.S. Department of Health and Human Services, supervising the Chief Counsel of the Health Care Financing Administration, Office of Inspector General, the Food and Drug Administration and the Public Health Service.

Mr. Charrow received his law degree from Stanford University and did his undergraduate work in physics at Harvey Mudd College in Claremont, California.